(a) Grounds and jurisdiction
(1) Any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce, or which may not, under the provisions of section 331(ll), 344, or 355 of this title, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States or United States court of a Territory within the jurisdiction of which the article is found. No libel for condemnation shall be instituted under this chapter, for any alleged misbranding if there is pending in any court a libel for condemnation proceeding under this chapter based upon the same alleged misbranding, and not more than one such proceeding shall be instituted if no such proceeding is so pending, except that such limitations shall not apply (A) when such misbranding has been the basis of a prior judgment in favor of the United States, in a criminal, injunction, or libel for condemnation proceeding under this chapter, or (B) when the Secretary has probable cause to believe from facts found, without hearing, by him or any officer or employee of the Department that the misbranded article is dangerous to health, or that the labeling of the misbranded article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer. In any case where the number of libel for condemnation proceedings is limited as above provided the proceeding pending or instituted shall, on application of the claimant, seasonably made, be removed for trial to any district agreed upon by stipulation between the parties, or, in case of failure to so stipulate within a reasonable time, the claimant may apply to the court of the district in which the seizure has been made, and such court (after giving the United States attorney for such district reasonable notice and opportunity to be heard) shall by order, unless good cause to the contrary is shown, specify a district of reasonable proximity to the claimant’s principal place of business, to which the case shall be removed for trial.
(2) The following shall be liable to be proceeded against at any time on libel of information and condemned in any district court of the United States or United States court of a Territory within the jurisdiction of which they are found: (A) Any drug that is a counterfeit drug, (B) Any container of a counterfeit drug, (C) Any punch, die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit drug or drugs, (D) Any adulterated or misbranded device, and (E) Any adulterated or misbranded tobacco product.
(3)
(A)
Except as provided in subparagraph (B), no libel for condemnation may be instituted under paragraph (1) or (2) against any food which—
(i) is misbranded under
section 343(a)(2) of this title because of its advertising, and
(ii) is being held for sale to the ultimate consumer in an establishment other than an establishment owned or operated by a manufacturer, packer, or distributor of the food.
(B)
A libel for condemnation may be instituted under paragraph (1) or (2) against a food described in subparagraph (A) if—
(i)
(I) the food’s advertising which resulted in the food being misbranded under
section 343(a)(2) of this title was disseminated in the establishment in which the food is being held for sale to the ultimate consumer,
(II) such advertising was disseminated by, or under the direction of, the owner or operator of such establishment, or
(III) all or part of the cost of such advertising was paid by such owner or operator; and
(ii) the owner or operator of such establishment used such advertising in the establishment to promote the sale of the food.
Amendments
2012—Subsec. (g)(1). Pub. L. 112–144, § 709(a)(1), inserted “, drug,” after “device” wherever appearing.
Subsec. (g)(2)(A). Pub. L. 112–144, § 709(a)(2), inserted “, drug,” after “(B), a device”.
Subsec. (g)(2)(B). Pub. L. 112–144, § 709(a)(3), inserted “or drug” after “device” in introductory provisions and in cl. (ii).
Subsec. (i). Pub. L. 112–144, § 709(b)(2), added subsec. (i).
2011—Subsec. (h)(1)(A). Pub. L. 111–353 substituted “reason to believe” for “credible evidence or information indicating” and “is adulterated or misbranded” for “presents a threat of serious adverse health consequences or death to humans or animals”.
2009—Subsec. (a)(2)(E). Pub. L. 111–31, § 103(d)(1), added cl. (E).
Subsec. (d)(1). Pub. L. 111–31, § 103(d)(2), inserted “tobacco product,” after “device,” in first sentence.
Subsec. (g)(1). Pub. L. 111–31, § 103(d)(3), inserted “or tobacco product” after “device” wherever appearing.
Subsec. (g)(2)(A). Pub. L. 111–31, § 103(d)(4), inserted “or tobacco product” after “device” in introductory provisions.
2007—Subsec. (a)(1). Pub. L. 110–85 substituted “section 331(ll), 344, or 355” for “section 344 or 355”.
2002—Subsec. (h). Pub. L. 107–188 added subsec. (h).
1997—Subsec. (d)(1). Pub. L. 105–115 substituted “subparagraphs (A) and (B) of section 381(e)(1) of this title” for “paragraphs (1) and (2) of section 381(e) of this title” and inserted “Any person seeking to export an imported article pursuant to any of the provisions of this subsection shall establish that the article was intended for export at the time the article entered commerce.” before “Any article condemned by reason”.
1993—Subsec. (a)(1). Pub. L. 103–80, § 3(f)(1), substituted “found. No libel” for “found: Provided, however, That no libel”.
Subsec. (d)(1). Pub. L. 103–80, § 3(f)(2), substituted “sold. After entry” for “sold: Provided, That after entry”, “met. The provisions of this sentence” for “met: Provided, however, That the provisions of this sentence”, “title. Where such exportation” for “title: And provided further, That where such exportation”, and “the preceding sentence shall not be applicable” for “the foregoing proviso shall not be applicable”.
1992—Subsec. (d)(1). Pub. L. 102–300 substituted “381(e)” for “381(d)” in three places and “paragraphs” for “clauses” before “(1) and (2) of section 381(e)”.
1976—Subsec. (a)(1). Pub. L. 94–295, § 3(c)(1), struck out “device,” after “Any article of food, drug,”.
Subsec. (a)(2). Pub. L. 94–295, § 3(c)(2), (3), added cl. (D) covering adulterated or misbranded devices.
Subsec. (a)(3). Pub. L. 94–278 added par. (3).
Subsec. (g). Pub. L. 94–295, § 7(a), added subsec. (g).
1970—Subsec. (a)(2). Pub. L. 91–513, § 701(c), struck out cls. (A) and (D) which dealt with depressant or stimulant drugs, struck out reference to depressant or stimulant drugs in cl. (C), and redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C), respectively.
Subsec. (d)(3)(iii). Pub. L. 91–513, § 701(d), struck out reference to depressant or stimulant drugs.
1968—Subsec. (a). Pub. L. 90–639 inserted references to the United States courts of Territories.
1965—Subsec. (a). Pub. L. 89–74, § 6(a), designated existing provisions as par. (1), redesignated cls. (1) and (2) of proviso as (A) and (B), and added par. (2).
Subsec. (b). Pub. L. 89–74, § 6(b)(1), inserted “equipment, or other thing proceeded against” after “article” in first sentence.
Subsec. (d). Pub. L. 89–74, § 6(b)(2), designated existing provisions as par. (1), redesignated cls. (1) and (2) of the second sentence thereof as (A) and (B), and added pars. (2) and (3).
1957—Subsec. (d). Pub. L. 85–250 permitted, under certain circumstances, reexportation of articles condemned at places other than original port of entry.
1953—Subsec. (c). Act Aug. 7, 1953, provided that a true copy of the analysis in any case shall be furnished the owner.
1948—Subsec. (a). Act June 24, 1948, inserted “or while held for sale (whether or not the first sale) after shipment in interstate commerce” to make this subsection coextensive with section 331(k) of this title.
Effective Date of 2012 Amendment
Pub. L. 112–144, title VII, § 709(c), July 9, 2012, 126 Stat. 1070, provided that:
“The amendments made by subsection (a) [amending this section] shall not take effect until the Secretary has issued a final regulation under subsection (b) [amending this section and enacting provisions set out as a note under this section].”
[Final regulation issued May 29, 2014, effective June 30, 2014. See 79 F.R. 30716.]
Effective Date of 2011 Amendment
Pub. L. 111–353, title II, § 207(c), Jan. 4, 2011, 124 Stat. 3944, provided that:
“The amendment made by this section [amending this section] shall take effect 180 days after the date of enactment of this Act [Jan. 4, 2011].”
Effective Date of 1997 Amendment
Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.
Effective Date of 1976 Amendment
Pub. L. 94–278, title V, § 502(c), Apr. 22, 1976, 90 Stat. 413, provided that:
“The amendments made by subsection (a) [amending this section and sections 321, 333, and 343 of this title] shall take effect 180 days after the date of the enactment of this Act [Apr. 22, 1976].”
Effective Date of 1970 Amendment
Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.
Effective Date of 1968 Amendment
Amendment by Pub. L. 90–639 applicable only with respect to violations of this chapter committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Effective Date of 1968 Amendments; Transitional Provisions note under section 321 of this title.
Effective Date of 1965 Amendment
Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.
Regulations
Pub. L. 112–144, title VII, § 709(b)(1), July 9, 2012, 126 Stat. 1069, provided that:
“Not later than 2 years after the date of the enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall promulgate regulations in accordance with section 304(i) of the Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 334(i)], as added by paragraph (2) of this subsection, to implement administrative detention authority with respect to drugs, as authorized by the amendments made by subsection (a) [amending this section]. Before promulgating such regulations, the Secretary shall consult with stakeholders, including manufacturers of drugs.”
Pub. L. 111–353, title II, § 207(b), Jan. 4, 2011, 124 Stat. 3944, provided that:
“Not later than 120 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall issue an interim final rule amending subpart K of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section [amending this section].”
Savings Provision
Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.
Construction of 2011 Amendment
Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.